Since the knowledge that blood borne pathogens and diseases can be passed from the carrier to another being, science has been concerned about the possibility of accidental needle puncture by unshielded sharp needles. Recently with the advent of the spread of AIDS and Hepatitis strains through blood contact, there has been added emphasis on the need to prevent accidental needle puncture by those using the needles or by those whose task it is to dispose of used needles. Also there exist a need to prevent secondary use of hypodermic style needles by those outside of the medicinal users, such as intravenous drug abusers, in the prevention to reduce the spread of these diseases that are spread by contact with contaminated blood. As technology has improved, so has the ability for needle manufacturer to develop sharper needles with smaller bores, increasing the chance of accidental puncture by these smaller sharper needles. Technology has also increased the safety of certain medications, in particular insulin to allow for non-medical personnel to administer or in some cases, self administer, injections of these medications. These non-medical users do not have the level of experience of medical personnel in the use of sharps containment, nor in many cases, do they have the financial means to use expensive injection devices that integrally contain sharp needle containment devices. Typically, these users are using non-refillable or single use injection devices. Unfortunately recently, used single-use hypodermic needles that have not been properly covered and disposed of, have found their way into city streets and have washed up on public beaches.
OSHA in it's 1991 Blood Borne Pathogens Standard, codified under 29 CFR 1930.1030, has noted that re-capping or containment of contaminated needles must be done through the use of a mechanical device or a one-handed technique, immediately or as soon as possible after use. These containment devices serve two purposes; one is to prevent accidental needle puncture, and secondly to contain or encapsulate any blood, and thus blood borne diseases, from being able to discharge from the needle into non-contaminated areas where human contact is possible. Thus, there exists a need for an inexpensive, easy to use, compact and reliable sharps containment device that will cover the sharp needle and prevent evacuation of contaminated fluids, after use and throughout the disposal process, after being used by either experienced medical or non-medical personnel. This invention defines a method of designing a device which can permanently hold a medical sharps, such as needles or trocars, in such a device that permanently retards their ability to be re-used.
Currently available sharps containment devices that protect the sharp tip of the needle can be broken down into three classes; those that cover the entire needle, those that slide down and protect only the tip of the needle, and those that where the user inserts the needle into a device. In the class of protectors that cover the entire needle after use, there is either an external sheath that is not integral to the hypodermic needle syringe body or an object that flips down on a pivot to cover the used needle. This sheath is either positioned along with the entire syringe body, as U.S. Pat. No. 5,558,649 issued to Shields on Sep. 24, 1996 and U.S. Pat. No. 5,851,196 issued to Arnett on Dec. 22, 1998 disclose, or is placed onto the needle hub, as U.S. Pat. No. 4,725,267 issued to Vaillancourt on Feb. 16, 1988, and U.S. Pat. No. 4,887,998 issued to Martin et al on Dec. 19, 1989 disclose. These are attached after the initial manufacture of the syringe body increasing cost and complexity of the process. Attaching these devices to the syringe body or needle hub increases the chance of chipping or damaging the end of the fragile needle, causing a burr, which causes the patient much unneeded pain. Also the devices are attached when the needle is exposed, increasing the risk of accidental needle puncture, the very act that is trying to be eliminated. There are also issues regarding the sterilization of these attached devices. Once the sterile package is opened to install these shields, the syringe must be immediately used or must be re-sterilized. This added step complicates activities in medical situations where extra steps could lead to time better spent saving patients, especially in settings outside of the hospital. The action to cover the needle, once the sheath is retracted for use, with these devices is to activate the returning of the sheath to the cover position by slight mechanical force. Accidental discharge of the devices holding the needle sheath in the retracted or use position, will render the syringe device completely unusable. Another drawback from using this style is the inability of the device to completely encapsulate the needle tip to prevent leakage of contaminated fluids. There must an opening that allows the sheath to be in a retracted position over the needle. Some of these sheathes also use unique or proprietary syringe bodies where special ribbing or holding devices that have been attached to facilitate the addition of the sliding cover. This adds greatly to the cost of the devices and adds many unique parts to hospital inventories, who are trying to reduce their inventory carrying costs. Prior art of this style is typified by U.S. Pat. No. 4,927,018 issued to Yang on May 22, 1990. Such special needles are expensive and do not integrate with current medical practices that seek to use devices that are accepted as standards in the industry. Other styles are designed solely for catheters, such as U.S. Pat. No. 5,769,827 issued to DeMichele et al. on Jun. 23, 1998, where it uses a special needle along with a proprietary syringe body. These aforementioned prior arts are constructed so that the needle hub is completely covered by the device prohibiting the removal of the needle from the syringe body. Other styles are designed for specific medical practices or procedures, such as U.S. Pat. No. 6,478,780 issued to Shields on Nov. 12, 2002, where this expensive and complex device is designed for only dental or plastic surgery applications.
The flip down style is also attached to the needle hub as a secondary operation to the manufacture of the syringe. Some are installed onto an open, unprotected needle prior to use. U.S. Pat. No. 4,664,259 to Landis issued on May 12, 1987, and U.S. Pat. No. 6,319,232 to Kashmer on Nov. 20, 2001 disclose a package that is attached to the needle hub. As before, to attach this device to the needle hub requires the needle be exposed, allowing the possibility of needle chipping, or needle puncture. Also due to the need to have clearance to open the device to use the needle, there are openings where contaminated blood or other bodily fluids can escape from the needle and possibly infect others. U.S. Pat. No. 6,413,243 to Geist issued on Jul. 2, 2002 does not have the problem of openings where blood can escape or having to expose the needle to attach the device, but presents an overly complex device, with latching members and interlocking engaging members, that require two-handed operation of this device. It also is very expensive for the average user and also presents a bulky operation not suited to emergency activities or to the single user without assistance of other medical personnel. U.S. Pat. No. 6,592,556 to Thorne issued on Jul. 15, 2003 eliminates the abovementioned problem of attachment to an unprotected needle and two handed operation, but does not completely encase the needle allowing for contaminated fluid discharge, as well as being an expensive attachment for the average user. U.S. Pat. No. 6,695,819 to Kobayashi issued on Feb. 24, 2004 combines a flip down needle protector that integrates with a needle cover. This device also is attached onto an unprotected needle and uses a proprietary needle cover and the flip down device does not cover the entire needle allowing for contamination. This device, by it design, does not allow for one-handed operation, which is critical to OSHA guidelines and emergency use, where emergency personnel are often performing multiple tasks at a single moment, such as holding down an IV tube into which the contents of the syringe will be emptied. Single handed operation of the needle protection device is a must in these situations.
In the arena of those devices that slide down and protect only the tip of the needle, U.S. Pat. No. 6,595,955 to Ferguson et al, issued on Jul. 22, 2003, discloses use of the device on a hypodermic needle, that must first be slid down the needle bore in order to be in the correct location for use after the syringe has been used. There are four inherent problems with this approach, as the needle is exposed during the task of installing the device, subjecting the user to accidental puncture; the device is too big to fit on today's small shorter hypodermic needle; the addition of this device to the needle creates an obstruction to the user in positioning the needle in the optimal striking angle into the skin or the user must be cognizant of the position of the device when using the needle, an additional item with which to be concerned in emergency situations; the device requires two handed operation to properly and safely use the device. Other prior art includes the use of such devices on much larger catheter style needles. U.S. Pat. No. 5,183,468 to McLess, issued on Feb. 2, 1993, discloses the fact that the device that is placed on the hub of the needle prior to use requires the use of a longer needle and also discloses that smaller devices of this style require close tolerances and miniaturized components, that both greatly increase the cost of the device to the user. U.S. Pat. No. 4,952,207 to Lemieux issued on Aug. 28, 1990, discloses a device that requires a special needle with a slot cut into the tip section for the device to attach onto for a secure fit. These special needles are expensive and do not fit into the need for standardizing needles and syringes throughout the medical community. U.S. Pat. No. 5,533,974 to Gaba issued on Jul. 9, 1996 discloses a spring powered latching device that is complex to manufacture and is to suitable for the smaller hypodermic needles.
Finally, those devices that are designed so that the user inserts the needle into the device which prevents withdrawal of the needle therefrom are examined. The current invention falls into this category. This methods avoids the problems with the aforementioned prior art, whereby the user does not prematurely subject themselves to the chance of accidental puncture or damage of the needle by having to install in the device onto the needle, allows for single handed operation, completely seals the needle from escape of contaminated fluids and is not a hindrance to use as the device is not in the line of sight or use, by merely being located on the needle itself. There are two main methods of preventing the user from withdrawing the needle from the device, once it is inserted; Either Chemical or Mechanical. In the chemical arena, the devices either capture the needle in a chemical compound that hardens to prevent removal, such as U.S. Pat. No. 5,322,165 to Melker issued on Jun. 21, 1994 using two part resin, U.S. Pat. No. 4,900,500 to Honeycutt issued on Feb. 13, 1990 using oligomer or monomer composition, U.S. Pat. No. 4,845,923 to Donovon issued on Jul. 11, 1989 using polyurethane foam, U.S. Pat. No. 5,368,576 to Brown et al, issued on Nov. 29, 1994 using a curable adhesive or U.S. Pat. No. 6,332,534 to Hammett issued on Dec. 25, 2001 using an epoxy resin. The problem with chemical hardening is the time it takes to secure the needle into the mixture as the mixture hardens around the needle as well as the problem associated with how fragile the unit is to accidental contamination of the agents causing premature hardening. The devices are not suited for emergency situations where speed is critical to success. Other devices are large table mounted units, not suitable for field applications, such as U.S. Pat. No. 6,545,242 to Butler issued on Apr. 8, 2003, which actually melts the needle destroying the needle from further use and also any associated contamination on the needle. In the mechanical arena, a syringe with the needle attached is placed into a device which holds it securely, retarding it's further use. U.S. Pat. No. 6,511,461 to Jonsson issued Jan. 28, 2003 discloses a device which is designed for needles performing extracorporeal blood processing where the needle is only held through friction between the needle and a deformable disk, which is not a sufficient amount of retardation as the patent discloses the possibility of dislodging the syringe needle from the device in the presence of force. Any possibility of dislodgment is not acceptable when persons outside of the medical needs situation, can recover needles and use the syringe and needle for illicit use. U.S. Pat. No. 5,395,338, which is a continuation of U.S. Pat. No. 5,417,659 to Gaba issued on Mar. 7, 1995 and May 23, 1995 respectively, disclose prior art most closely associated with the present invention. Gaba claims a foil which uses a wedging element along with a biasing element and a gripping element to create a binding force to hold the needle in position inside of the foil. This combination creates four principle problems. Firstly, the combination of the 3 elements creates a stack of elements that are too tall for the newer shorter units and as Gaba claims a stop for limiting needle insertion, the shorter needles will not be gripped by the gripping element. By design, there will always be an extra element that the current invention does not possess, the wedging element. The preclusion of that element creates the shorter stack height that is necessary. Secondly, the wedging elements are difficult to assemble properly, causing slow production cycles or quality failures. The direction of the bias or discontinuity on the gripping element must face away from the opening of the device, and the operator is forced to examine each gripping element for the direction of the bias. Trying to find the bias of the wheel is difficult as the bias is in the same color as the wheel and the bias is less than 0.0005 in height. This lack of definition makes cheaper more automated forms of assembly, such as robotic assembly, very difficult and expensive as extensive vision systems are required. Failure to orientate the bias properly will lead to failure of the device as the needle will slip against the gripping element. These quality failures are not discoverable once the unit is sealed until the foil is used. Improper assembly causes the gripping element not to grab the needle with sufficient force to hold the needle in place. Thirdly, Gaba discloses the necessity for the discontinuity of the gripping element to be sharp. Gaba claims that the discontinuity will distort the sharp in claim 3 of Gaba '659, so that there is a mechanical interference so that the wedging element performs properly. With advances to needle technology where stronger needles are being sought and designed, there is no method to assure that future needles are distortable by the Gaba device. Also, other medical sharps like blades, disclosed by Gaba, constitute a class of medical sharps that by their nature deter the ability to distort their shapes as this quality would be detrimental to their medical performance raising doubts as the adequate performance of the Gaba device. The current invention uses the principle of mechanical leverage not friction to prevent the retracting of medical sharps which precludes the need to mechanically distort the medical sharp. Leverage is defined as a force transmitted through a pivoted point by an object. The mechanical leverage comes about as the gripping means are forcibly rotated about the pivot point. As the sharp is attempting to be withdraw from the invention, the gripping means are forced or leveraged against one other, as the pivot point is not along the centerline of the gripping means, thereby trapping the sharp between the gripping means. Fourthly, current adaptation of the Gaba patent has a cover that slips onto the device, whose purpose is to engage the hub of the needle and allow the user to rotateably remove the needle from the syringe body. This cover can be relocated from its position on the device, along the shaft of a needle, so that once the needle is inserted into the Gaba device, the user can slide the cover up to the hub of the needle and rotate the syringe body until the needle is separated from the syringe body. This cover has two inherent problems. Firstly, the cover adds to the height of the stack, further precluding the use of short needles as the height of the stack is increased by about 25%. Secondly, the cover must be attached prior to use of the device. If the user decides after the fact to remove the needle from the syringe body, the user is not able to use the cover for that operation.
It would be desirable to have a apparatus that is able to work with needles of all different medical, dental, veterinary types of needles, devoid of the problems associated with the prior art, and is able to provide this protection in a cost-effective manner. Another embodiment of the present invention is that it also functions separately as a apparatus to hold needles so that they can be removed from the syringe bodies. A separate wrench that is attachable even after the needle is inserted into the apparatus is adapted for use. This wrench can also be detached from the apparatus after the needle has been removed from the syringe body, and the wrench can be reused on another apparatus. This reusability is a desirable function.
The current invention also includes a multiple apparatus arrangement whereby more than 1 apparatus is available for use at any one time. During surgery, many needles are used in rapid succession causing the need for one unit to adapt to many needles quickly. It would be desirable to have an apparatus that is small enough to fit into the crowded surgical trays used in today's operating room, and yet be stable enough to resist tipping.